The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0847.
Cellcept 250mg Capsules
CellCept 250 mg hard capsules
1. What CellCept is and what it is used for
2. What you need to know before you take CellCept
3. How to take CellCept
4. Possible side effects
5. How to store CellCept
6. Contents of the pack and other information
CellCept contains mycophenolate mofetil.
CellCept is used to prevent your body rejecting a transplanted organ.
CellCept should be used together with other medicines:
Mycophenolate causes birth defects and miscarriage. If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies. Read the information carefully and follow the instructions.
If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate. See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking CellCept.
Talk to your doctor straight away before starting treatment with CellCept:
If any of the above apply to you (or you are not sure), talk to your doctor straight away before starting treatment with CellCept.
CellCept reduces your body’s defences. As a result, there is an increased risk of skin cancer. Limit the amount of sunlight and UV light you get. Do this by:
Do not give this medicine to children younger than 2 years because based on the limited safety and efficacy data for this age group no dose recommendations can be made.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, such as herbal medicines. This is because CellCept can affect the way some other medicines work. Also other medicines can affect the way CellCept works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start CellCept:
If you need to have a vaccination (a live vaccine) while taking CellCept, talk to your doctor or pharmacist first. Your doctor will have to advise you on what vaccines you can have.
You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment. Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Taking food and drink has no effect on your treatment with CellCept.
If you are a woman who could become pregnant, you must use an effective method of contraception with CellCept. This includes:
Talk to your doctor about the most suitable contraception for you. This will depend on your individual situation. Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy.
Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
You cannot become pregnant if any of the following conditions applies to you:
The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate. However, a risk cannot be completely excluded. As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.
If you are planning to have a child, talk to your doctor about the potential risks and alternative therapies.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately. However, keep taking CellCept until you see him or her.
Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (23 - 27%) in the unborn baby. Birth defects that have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed). Your baby may be affected by one or more of these.
If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor. Your doctor may request more than one test to ensure you are not pregnant before starting treatment.
Do not take CellCept if you are breast-feeding. This is because small amounts of the medicine can pass into the mother’s milk.
CellCept has a moderate influence on your ability to drive or use any tools or machines. If you feel drowsy, numb or confused, talk to your doctor or nurse and do not drive or use any tools or machines until you feel better.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The amount you take depends on the type of transplant you have had. The usual doses are shown below. Treatment will continue for as long as you need to prevent rejection of your transplant organ.
Children (aged 2 to 18 years)
Swallow your capsules whole with a glass of water
Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
Take care not to let any powder from inside a broken capsule get onto your skin.
If you take more CellCept than you should, talk to a doctor or go to a hospital straight away. Also do this if someone else accidentally takes your medicine. Take the medicine pack with you.
If you forget to take your medicine at any time, take it as soon as you remember. Then continue to take it at the usual times. Do not take a double dose to make up for a missed dose.
Do not stop taking CellCept unless your doctor tells you to. If you stop your treatment you may increase the chance of rejection of your transplant organ.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, CellCept can cause side effects, although not everybody gets them.
Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to check for any changes in:
Children may be more likely than adults to have some side effects. These include diarrhoea, infections, fewer white cells and fewer red cells in the blood.
CellCept reduces your body’s defences. This is to stop you rejecting your transplant. As a result, your body will not be as good as normal at fighting infections. This means you may catch more infections than usual. This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
As can happen in patients taking this type of medicine (immune-suppressants), a very small number of patients on CellCept have developed cancer of the lymphoid tissues and skin.
You may get general side effects affecting your body as a whole. These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Other unwanted effects may include:
Skin problems such as:
Urinary problems such as:
Digestive system and mouth problems such as:
Nervous system problems such as:
Heart and blood vessel problems such as:
Lung problems such as:
Other problems such as:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in April 2022